Almatica Company Profile

What is the competitive landscape for ALMATICA, and what generic alternatives to ALMATICA drugs are available?

ALMATICA has fourteen approved drugs.

There are nine US patents protecting ALMATICA drugs.

There are fifty-eight patent family members on ALMATICA drugs in thirty countries and forty-three supplementary protection certificates in sixteen countries.

Summary for Almatica

International Patents:	58
US Patents:	9
Tradenames:	15
Ingredients:	14
NDAs:	14

Drugs and US Patents for Almatica

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Almatica	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	202133-001	Oct 6, 2011	AB	RX	Yes	Yes
Almatica	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	AB	RX	Yes	Yes
Almatica	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Almatica	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760-001	Jun 8, 1984	AB	RX	Yes	Yes
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	BX	RX	Yes	Yes	8,192,756		Y

Expired US Patents for Almatica

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	TENORMIN	atenolol	TABLET;ORAL	018240-001	Approved Prior to Jan 1, 1982	3,934,032
Almatica	TENORMIN	atenolol	TABLET;ORAL	018240-004	Apr 9, 1990	3,934,032
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	8,333,992
Almatica	ZESTRIL	lisinopril	TABLET;ORAL	019777-004	May 19, 1988	4,374,829*PED
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	6,635,280
Almatica	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	8,252,332

Paragraph IV (Patent) Challenges for ALMATICA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	450 mg		2013-02-28
	Tablets	300 mg and 600 mg		2011-10-31

Premature patent expirations for ALMATICA

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

International Patents for Almatica Drugs

Country	Patent Number	Estimated Expiration
Australia	2005267738
World Intellectual Property Organization (WIPO)	2014110245
Croatia	P20210236
European Patent Office	2943185
Canada	2897302
Denmark	1439825

Supplementary Protection Certificates for Almatica Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	CA 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
0984957	PA2011005,C0984957	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
1411900	122012000052	Germany		PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Almaject
• Almatica